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Last Updated: December 26, 2024

Details for New Drug Application (NDA): 091328

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NDA 091328 describes LEVONORGESTREL, which is a drug marketed by Wyeth Pharms Inc, Alvogen, Fdn Consumer, Glenmark Pharms Ltd, L Perrigo Co, Laboratoire Hra, Lotus Pharm Co Ltd, Lupin Ltd, Naari Pte Ltd, Novel Labs Inc, Perrigo R And D, Watson Labs, Xiromed, Amneal Pharms, Barr, Dr Reddys Labs Sa, and Hetero Labs, and is included in forty-six NDAs. It is available from fourteen suppliers. Additional details are available on the LEVONORGESTREL profile page.

The generic ingredient in LEVONORGESTREL is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.

Summary for 091328

Tradename:	LEVONORGESTREL
Applicant:	Lupin Ltd
Ingredient:	levonorgestrel
Patents:	0

Medical Subject Heading (MeSH) Categories for 091328

Contraceptive Agents, Female
Contraceptives, Oral, Synthetic

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	0.75MG
Approval Date:	Jan 23, 2013	TE:		RLD:	No

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